Multi Center Prospective Registry of Infliximab Use for Childhood Uveitis

Inclusion Criteria:.

• Ages 4 to 18 years old,
• Non-infectious uveitis
• Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
• Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
• Ability to provide informed consent (subject or parent/guardian)
• Onset of uveitis < 16 years of age.
• Topical ophthalmologic treatments allowed.
• Systemic corticosteroid use at entry may be allowed.
• Willingness to use acceptable contraception if sexually active for the duration of the study and for 6 months after receiving the last infliximab infusion.
• Concomitant methotrexate must be taken at time of initiation of infliximab
• Participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination.
• Negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab
• The screening laboratory test results must meet the following criteria:
• WBC (white blood cell count): within normal range for institution
• ANC (absolute neutrophil count): within normal range for institution
• Hemoglobin: greater than 10 grams/deciliter
• Platelets: within normal range for institution
• Serum Creatinine: within normal range for age
• AST - aspartate aminotransferase - within normal range for institution
• ALT - alanine aminotransferase- within normal range for institution

Exclusion Criteria

• Previous use of biologic medications for uveitis.
• Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
• Uveitis due to trauma or intraocular surgery
• Females who are pregnant, nursing, or planning pregnancy within 6 months after the last infliximab infusion.
• Males who plan on fathering a child within 6 months after their last infliximab infusion.
• A history of a known allergy to murine products.
• Documentation of seropositivity for human immunodeficiency virus (HIV).
• Documentation of a positive test for hepatitis B surface antigen or hepatitis C
• A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
• An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
• A concomitant diagnosis or history of congestive heart failure.
• A history of lymphoproliferative disease.
• Any known malignancy or a history of malignancy.
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
• Use of any investigational drug within 30 days prior to screening or within five half-lives of the first dose of the investigational agent, whichever is longer.
• Presence of a transplanted solid organ.